Role Summary
Responsible for study oversight and delivery management (time, budget, quality) at country level from start-up to closure.
Key Responsibilities
- Serves as the main point of contact at a country level for internal and external stakeholders
- Coordinates country cross functional teams and acts as the main point of contact for a Country with the protocol manager and other global study team members
- Coordinates with other internal roles in country and site feasibility process, including proposal and validation of country study targets
- Develops country level patient recruitment strategy & risk mitigation. Coordinates and ensures country level study enrolment targets and timelines are met
- Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s
- Assessment and set up the of vendors during study start up period (locally)
- Investigator Meeting participation and preparation
- Ensures data entered in Clinical Trial Managements Systems is current and complete and access to eDC and vendor systems is available for the Country and clinical trial site personnel
- Validation of study related materials (i.e. protocol, ICF, patient material)
- Responsible for preparing country specific documents (e.g. global country specific amendment)
- Prepares materials for Site Initiation Visits
- Responsible for verifying and confirming with local team eTMF completeness (Country and Site level)
- Reviews Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues
- Coordination of database locks and query follow up. Ensures timelines are met
- Ensure inspection readiness of assigned trials within country. Provide support to Health Authority inspection and pre- inspection activities
- Coordinates, develops and writes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings
- Drives CAPA review, implementation and completion
- Lead study team meetings locally
- Reviewing and approving payments (based on GOA) and manage patient compensation claims (if applicable)
- Management of Site relationships (includes CRO related issues)
- May conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs)
- May perform site closure activities, including post-close out
- May act as point of contact for Sites
- May support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instances
Additional responsibilities:
- Responsible for the end-to-end management of budgeting and contracting for Study Teams with a focus on contracting a variety of contracts & study types including Confidential Disclosure Agreements (CDAs), Investigator contracts for BMS sponsored studies, non-registrational
- Provide knowledgeable single-point of service to study teams related to study budgets and contracts
- Prepare study /site level grant budgets
- Manage the end-to-end process for executing Clinical Trial Agreements (CTAgs) with investigator sites
- Prepares contract documents from templates and modify to reflect unique aspects of the particular study, including (the CTAg financial appendix)
- Negotiates financial and legal aspects of CTAg and Master Service Agreements with sites, Institutions or vendor personnel
- Is trained on legal fall back language and works with Legal as needed
- Communicates clearly and efficiently with BMS Clinical and Legal Teams regarding amendments and other issues Enter CTAg, documents and data into Clinical Trial Management System and contract management software and ensure correct filing
- Preparation, negotiation and execution of Master Agreements with Institution
- Develop and maintain template language in collaboration with legal for all contract types. Would include maintenance of associated back-up language
- Escalate to appropriate BMS colleague when a significant risk to the business is identified
Degree/Certification/Licensure:
- Bachelor’s degree required preferably within life sciences or equivalent
Experience – Responsibility and minimum number of years
- Clinical Trial Manager: Minimum of 4 years’ industry related experience
- Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives
Competencies – knowledge, skills, abilities, other
- Thorough understanding of GCP, ICH Guidelines and Country regulatory environment
- In depth knowledge and understanding of clinical research processes, regulations and methodology
- Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
Software that must be used independently and without assistance
- Microsoft Suite
- Clinical Trial Management Systems (CTMS)
- Electronic Data Capture Systems (eDC)
- Electronic Trial Master File (eTMF)